Catheter systems, kits, and methods for gaining access to a vessel

ABSTRACT

Some of the present methods include, and some embodiments of the present systems are configured for gaining access to a patient&#39;s vessel by way of the vessel (i.e. from the inside out). Some embodiments facilitate gaining access to an occluded vessel, where part of the access path is through the occlusion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/301,397 filed Feb. 29, 2016, the entire contents of which isspecifically incorporated herein by reference without disclaimer.

BACKGROUND

1. Field of Invention

The present invention relates generally to catheter systems, kits, andmethods of using the catheter systems and kits useful for gaining accessto a vessel by way of the vessel.

2. Description of Related Art

Access to a patient's vascular system, e.g., the central venous orarterial system, of a patient can be necessary to carry out manylifesaving medical procedures. For example, the usual method of gainingaccess to the venous system in the area of the neck is to directlypuncture a major vein in the neck with a large gauge needle throughwhich a guide wire is placed. This approach is described as going fromthe outside (skin) to inside the vein/vessel. The guide wire supportsthe remainder of the intervention at the site that usually results inthe placement of an introducer sheath or the like. A problem can arisehowever when a major vein is blocked with a clot or fibrous occlusion.Similarly, a problem can also arise when an artery is blocked with aclot or fibrous occlusion.

SUMMARY

Embodiments of the present disclosure facilitate gaining access to apatient's vessel by way of the patient's vasculature (i.e. from theinside out). Some embodiments facilitate gaining access to an occludedvessel, where part of the access path is through the occlusion. Theocclusion is first penetrated by a needle wire and then by a largerdiameter catheter that then directs a second catheter along a path thatis at an angle to the longitudinal axis of the larger diameter catheter(e.g., projection angle). In some embodiments, the occluded vessel is inthe upper chest and/or neck (e.g., at a location near the clavicle).

One embodiment of the present disclosure is a method for providingaccess to a central venous system of a patient. Such methods cancomprise: applying a radiopaque target having a radiopaque area and aradiolucent area to the skin of the patient so that the radiolucent areadefines an exit point on the skin of the patient introducing a catheterand a projection angle catheter into the patient in an area remote fromthe exit point, wherein the projection angle catheter is configured toextend out a side aperture of a distal tip of the catheter at aprojection angle, and a needle wire is configured to extend through theprojection angle catheter, wherein the catheter has a aperture at adistal end of the distal tip configured such that the needle wire canextend through the aperture advancing the needle wire through the distalend aperture of the catheter to a desired location in the central venoussystem; advancing the catheter to position said distal tip in a desiredtip location in the central venous system; viewing the catheter and saiddistal tip under fluoroscopy through the radiolucent area of theradiopaque target; rotating the catheter so that the side aperture andtherefore the projection angle plane is aligned with the radiolucentarea of the radiopaque target; adjusting the projection angle catheterso that the projection angle is aimed at the radiolucent area of theradiopaque target; and advancing the needle wire through the projectionangle catheter, such that the distal end of the needle wire advances atan angle relative to the catheter and penetrates the skin of the patientadjacent the radiolucent area of the radiopaque target thereby providinga distal end of the needle wire exterior to the skin.

Another embodiment for providing access to a central venous system of apatient can comprise: introducing a catheter into the patient, whereinthe catheter has a projection angle catheter configured to extend out aside aperture of a distal tip of the catheter at a projection angle, anda needle wire configured to extend through the projection anglecatheter, wherein the catheter has an aperture at a distal end of thedistal tip configured such that the needle wire can extend through theaperture in a direction substantially parallel with a longitudinal axisof the catheter, wherein the projection angle is angled with respect tothe longitudinal axis; advancing the needle wire through the distal endaperture of the catheter and into a vessel occlusion; advancing thecatheter to position said distal tip in a desired tip location;retracting the needle wire into the catheter and the projection anglecatheter; advancing the projection angle catheter so that the catheterextends through the side aperture; and advancing the needle wire throughthe projection angle catheter and through the skin of the patient,thereby providing a distal end of the needle wire exterior to the skin.

Another embodiment of the present disclosure can comprise a cathetersystem. Such systems can comprise: a first catheter that can comprise ashaft comprising a proximal end and a distal end extending along alongitudinal axis and defining a lumen extending therebetween; a distaltip disposed at the distal end of the shaft and defining a lumenextending along a longitudinal axis and in fluid communication with theshaft lumen and comprising a distal end, wherein the distal tipcomprises a side aperture in fluid communication with the shaft lumenand an aperture at the distal end in fluid communication with the shaftlumen; a second catheter having a portion configured to extend throughthe shaft lumen and the side aperture, the second catheter comprising aproximal end and a distal end and defining a lumen along a longitudinalaxis between the proximal end and the distal end, wherein a portion ofthe second catheter is curved along the longitudinal axis and the curvedportion is closer to the distal end than the proximal end, wherein thefirst catheter and the second catheter are configured such that thedistal end of the second catheter passes through the side aperture ofthe first catheter when advanced through the first catheter; and aneedle wire configured to extend through the second catheter lumen andto extend through the distal end exit aperture of the first catheter ina direction substantially parallel with the longitudinal axis of theshaft, the needle wire having a sharp dissection tip, wherein the needlewire is configured such that it can penetrate a muscle tissue withoutdeflection.

The term “coupled” is defined as connected, although not necessarilydirectly, and not necessarily mechanically; two items that are “coupled”can be unitary with each other. The terms “a” and “an” are defined asone or more unless this disclosure explicitly requires otherwise. Theterm “substantially” is defined as largely but not necessarily whollywhat is specified (and includes what is specified; e.g., substantially90 degrees includes 90 degrees and substantially parallel includesparallel), as understood by a person of ordinary skill in the art. Inany disclosed embodiment, the term “substantially” can be substitutedwith “within [a percentage] of” what is specified, where the percentageincludes 0.1, 1, 5, and 10 percent.

Further, a device or system that is configured in a certain way isconfigured in at least that way, but it can also be configured in otherways than those specifically described.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), and “include” (and any form of include, such as “includes”and “including”) are open-ended linking verbs. As a result, an apparatusthat “comprises,” “has,” or “includes” one or more elements possessesthose one or more elements, but is not limited to possessing only thoseelements. Likewise, a method that “comprises,” “has,” or “includes” oneor more steps possesses those one or more steps, but is not limited topossessing only those one or more steps.

Any embodiment of any of the apparatuses, systems, and methods canconsist of or consist essentially of—rather thancomprise/include/have—any of the described steps, elements, and/orfeatures. Thus, in any of the claims, the term “consisting of” or“consisting essentially of” can be substituted for any of the open-endedlinking verbs recited above, in order to change the scope of a givenclaim from what it would otherwise be using the open-ended linking verb.

The feature or features of one embodiment can be applied to otherembodiments, even though not described or illustrated, unless expresslyprohibited by this disclosure or the nature of the embodiments.

Some details associated with the embodiments described above and othersare described below.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings illustrate by way of example and not limitation.For the sake of brevity and clarity, every feature of a given structureis not always labeled in every figure in which that structure appears.Identical reference numbers do not necessarily indicate an identicalstructure. Rather, the same reference number can be used to indicate asimilar feature or a feature with similar functionality, as cannon-identical reference numbers.

FIGS. 1A and 1B are schematic views of an embodiment of a cathetersystem. FIG. 1A illustrates a needle wire extending from a distal end,and FIG. 1B illustrates the needle wire and a catheter extending from aside aperture.

FIG. 1C is an isolated, magnified, top perspective view of the distaltip of the embodiment shown in FIGS. 1A and 1B.

FIG. 1D is an isolated, magnified, bottom perspective view of the distaltip of the embodiment shown in FIG. 1C.

FIG. 1E is a schematic, perspective view of the handle shown inembodiment of FIG. 1A.

FIG. 1F is a schematic, cross-sectional view of the handle shown in FIG.1E.

FIG. 2A is an isolated, magnified, top perspective view of a distal tipof another catheter system embodiment.

FIG. 2B is an isolated, cross-sectional view of the distal tip of theembodiment shown in FIG. 2A.

FIG. 2C is an isolated, cross-sectional view of the distal tip of theembodiment shown in FIG. 2A where the cross-section is taken on a planethat is transverse to that of FIG. 2B.

FIG. 3A is a cross-sectional, schematic view of a patient with a vesselocclusion involving a vessel in the upper chest region above the levelof the superior vena cava (SVC) and the right atrium. A portion of acatheter system embodiment is shown extending through the vessel.

FIGS. 3B-3H are schematic illustrations of a series of process steps ofan embodiment of using a catheter system, the illustration showing avessel with a vessel occlusion and the distal portion of a cathetersystem embodiment. FIG. 3A is similar to FIG. 3B yet provides a widerperspective of a catheter system extending through the vessel, proximalan occlusion.

FIG. 3I is a cross-sectional, schematic view of a patient with a vesselocclusion involving a vessel in the upper chest region above the levelof the superior vena cava (SVC) and the right atrium, and a portion of acatheter system embodiment extending through the vessel and into anocclusion.

FIG. 4 is a schematic of a radiopaque target embodiment aligned with adistal tip embodiment. Some or all of the elements may be viewable withradiographic imaging.

DETAILED DESCRIPTION

FIGS. 1A to 1D illustrate one embodiment of a catheter system 12. InFIGS. 1A and 1B, system 12 is shown as a schematic view with componentsof the system in different positions. Catheter system 12 comprises acatheter 20, a catheter 34 configured to extend at least partiallythrough catheter 20, and a needle wire 32 configured to extend throughcatheter 34. Catheter 20 comprises a shaft 18 having a proximal end 18 aand a distal end 18 b. Shaft 18 at proximal end 18 a is coupled to ahandle 28 through an optional resilient member 14 that defines a lumenin communication with the lumen of catheter 20. Distal tip 22 isdisposed at the distal end 18 b of shaft 18.

FIGS. 1C and 1D show a magnified top, perspective view and bottom,perspective view of a distal tip 22 of catheter 20. Distal tip 22defines a lumen 23 that is in fluid communication with the lumen ofshaft 18. Distal tip 22 comprises a side aperture 21 disposed between aproximal end 22 a and a distal end 22 b of the distal tip. Distal tip 22also comprises an aperture 29 at distal end 22 b. Both side aperture 21and aperture 29 are in fluid communication with lumen 23 of distal tip22. Distal tip 22 and needle wire 32 are configured such that the distalend of needle wire can extend through lumen 23 and distal end aperture29 (e.g., a transverse dimension of the aperture and conduit is greaterthan a maximum transverse dimension of the needle wire). Side aperture21 and catheter 34 are configured such that catheter 34 can extendthrough the side aperture (e.g., cross-sectional dimension of theaperture is greater than a maximum transverse, cross-sectional dimensionof catheter 34) when entering lumen 23 through proximal end 22 a. In theembodiment shown, the transverse cross-sectional area of lumen 23 isgreater at the proximal end 22 a than the distal end 22 b since thedistal end 22 b only needs to accommodate needle wire 32.

Distal tip 22 can also comprise side aperture 41 (FIG. 1C) and/or sideaperture 42 (FIG. 1D). Side apertures 41 and/or 42 can be disposedbetween proximal end 22 a and distal end 22 b of distal tip 22 and canbe in fluid communication with lumen 23 of distal tip 22. Distal tip 22can comprise a radiopaque material that defines at least a portion ofside aperture 41 and/or side aperture 42. Side aperture 41 and/or sideaperture 42 can be used as reference guide during the circumferentialalignment of catheter 20. The visibility of side aperture 41 and/or 42will vary with the axial rotation distal tip 22. When viewing areal-time radiographic image of distal tip 22, side apertures 41 and/or42 will appear widest and/or brightest when the plane of a radiographicdetector is aligned with (e.g., in the same plane as) apertures 41and/or 42. The aiming and alignment of the distal tip 22 will bedescribed in further detail below. This angle can be used to select theprojection angle at which catheter 34 extends from side aperture 21and/or define the exit path of a needle wire 32 advancing from catheter34. When the projection angle of catheter 34 substantially correspondsto the angle of the detector plane, the exit path of needle wire 32 willintersect the desired exit site on the patient. In some embodiments,side aperture 21 can also be defined by a radiopaque material tofacilitate the rotational alignment and angle setting process. Distaltip 22 can be coupled to or integral with shaft 18.

Catheter 34 is configured to extend through side aperture 21 at an anglerelative to the longitudinal axis Y of catheter 20. The angle is definedby the section of catheter 34 extending through side aperture 21 and isreferred to as the projection angle θ (see FIG. 3I). The projectionangle θ corresponds to the angle of the exit path 38 of needle wire 32relative to distal tip 22 (e.g., the angle of the tissue track).Catheter 34 and distal tip 22 can be configured such that the projectionangle can be selectively adjusted. For example, catheter 34 can comprisea resilient section 34 b near distal end 34 a that is curved along thelongitudinal axis of catheter 34 in a preformed shape. When disposedwithin catheter 20, curved section 34 b is held in a less curvedconfiguration by sidewall 52 of catheter 20. However, by advancingcatheter 34 in a distal direction, distal end 34 a becomes adjacent sideaperture 21 and the constraint by sidewall 52 is reduced and the curvedsection 34 b adopts a more curved or less constrained configuration. Asdistal end 34 a progressively extends through side aperture 21, theprojection angle θ increases. In this manner, catheter 34 moves througha range of projection angles θ as the length of catheter 34 extendingfrom side aperture 21 is increased or decreased. In some embodiments,the length (dimension along longitudinal axis Y) of side aperture 21 canbe such that the constraint on catheter 34 is sufficiently reduced andthe distal end 34 a is able to advance at an angle through side aperture21 and not intersect (e.g., clear or not get hung on) sidewall 52.

In some embodiments, catheter 34 is configured not to rotate (e.g.,spin) within the lumen of catheter 20. This restraint on rotationalmovement allows for the inner curved surface of curved section 34 b toremain facing in the direction of side aperture 21. This can assist inthe reliability of the exit of catheter 34 through the side aperture.One mechanism for restraining rotation within the lumen of catheter 20is to have a channel longitudinally disposed in surface of catheter 34that receives (e.g., interlocks with) a rigid protrusion that isdisposed in handle 28 or on the luminal surface of catheter 20 such thatlongitudinal movement is not restrained by this mechanism, onlyrotational movement.

In some embodiments, particularly those that are used to penetrate anocclusion, catheter 20 can be configured to be sufficiently push-able(in a proximal-distal direction) and/or torque-able to allow distal tip22 to be forced into a vessel occlusion (e.g., a thrombus). In someembodiments, catheter system 12 is configured such that the distal tip22 can penetrate a vessel occlusion without deflection. In someembodiments, an appropriate value of bending stiffness can be between30-60 (pounds force) times (inches squared) (e.g., about 30, 35, 40, 45,50, 55, or 60 (pounds force) times (inches squared)). For example, astainless steel tube with an inside diameter of 0.074 inches and outsidediameter of 0.094 inches would be sufficient for this purpose. Howeverit is understood that any variety of materials with various wallthicknesses can be pushed and/or torqued to force distal tip 22 into anocclusion. Other embodiments can comprise a polymeric tube. Such tubesmay comprise higher stiffness braided or coiled materials like metalsembedded in the polymer.

The magnitude of the forces required can also depend on the “sharpness”of the distal tip 22 and the overall diameter. In some embodiments, thetip can be blunted distal end or where the transverse cross-sectionalarea of the distal end 22 b is at least 1.5× the area of the aperture29. In other embodiments, the tip can have a distal end that taperstoward aperture 29 or where the transverse cross-sectional area of thedistal end 22 b is less than 1.5× the area of the aperture 29.

Needle wire 32 can be configured to penetrate a muscle tissue and/orthrombus at a distal end 32 a without deflection. For example, needlewire 32 can comprise a trocar-type tip or sharp dissection tip at distalend 32 a. Such tip can be blunted, flat and angled, conical, orpyrimidal in shape. Needle wire 32 can also have a bending stiffnesssufficient to penetrate a tissue without deflection. Suitable needlewire materials can include any medical grade material that can providethe material properties needed to perform the above function, e.g.,steel, titanium (e.g., titanium alloy or nitinol), or the like.

In some embodiments, the needle wire 32 is made of nitinol with 55-57%nickel and 43-45% titanium. For example, nitinol can comprise thefollowing composition (in wt %):

Chemical Composition (reference ASTM F2063) wt % Nickel (nominal) 55.96Titanium 43.98 Carbon 0.025 Cobalt 0.00033 Copper 0.00038 Chromium0.00024 Hydrogen 0.0001 Iron 0.0094 Niobium <0.00002 Oxygen 0.0288

In some embodiments, the diameter of needle wire 32 can be between 0.02in. to 0.03 in., e.g., 0.020 in., 0.021 in., 0.022 in, 0.023 in, 0.024in., 0.025 in., 0.026 in., 0.027 in., 0.028 in., 0.029 in., or 0.030 in.

In some embodiments, needle wire 32 can be a drawn filled tube wirecomprising a radiopaque core. In some embodiments, the outer sheath isnitinol. In some embodiments, the core can be at least located on thedistal end and not extending the entire length.

Catheter system 12 can further comprise handle 28. A magnified,isolated, and exterior view of handle 28 is provided in FIG. 1E and across-sectional view is provided in FIG. 1F. In embodiment shown, handle28 is approximately cylindrical with a central axis Y. Handle 28 can beconfigured to axially rotate distal tip 22 of catheter 20, catheter 20,and/or catheter 34. In some embodiments, handle 28 is configured suchthat its axial rotation axially rotates catheter 20 and/or catheter 34.This motion facilitates the rotational alignment of distal tip 22relative to a radiographic detector as described above.

Handle 28 can also be configured to advance catheter 34 through catheter20 and out of side aperture 21. In the embodiment shown, rotary knob 16is configured to turn in a clockwise and/or counter clockwise directionthereby advancing and/or retracting catheter 34. Handle 28 alsocomprises a gauge or scale 17 that indicates the projection angle θ ofcatheter 34. The position of catheter 34 and the projection angle θ isdisplayed on gauge or scale 17 in handle 28. Thus, knob 16 is configuredto adjust the projection angle θ of catheter 34 and adjust the readingfrom the scale 17. For example, knob 16 can be configured such that itsrotation turns a threaded body 19, whereby the threaded body's rotationadvances or retracts catheter 34 depending upon direction of rotation.Knob 16 can also be configured such that its rotation translates post 60within companion slot 61, whereby indicating the projection angle basedupon the post's position relative to scale 17.

Handle 28 can also be configured to advance and/or retract needle wire32 through catheter 34 and distal tip 22. For example, handle 28 cancomprise a wire clamping and propelling mechanism located within thehandle 28 that allows the user to advance the needle wire 32 out of thehandle. Wire clamping and propelling mechanism can comprise a J-armclamp 62 coupled to pommel 25. Pommel 25 is moveable with areciprocating motion (or piston-like motion), as indicated by motionarrow 27. Pommel 25 is coupled to J-arm clamp 62 that is configured towedge against needle wire 32 as the pommel is advanced distally and torelease the needle wire upon a return stroke of the pommel. J-arm clamp62 is configured to remain stationary while the pommel moves during thereturn stroke. Pommel 25 and handle 28 are configured to support thewire 32 during the stroke so that needle wire 32 does not bend or kink.The stroke is relatively fixed so that a user may count the number ofpommel strokes to have an estimate of how much needle wire 32 has beenadvanced. Retracting needle wire 32 can occur by proximally pulling thewire.

Handle 28 can also comprise a releasable locking mechanism 66 configuredto fix the axial position of needle wire relative to handle 28 so thewithdrawal of the handle also pulls the needle wire. When unlocked,needle wire 32 can move axially relative to handle to facilitate theremoval of catheters 20 and catheter 34 from body while the needle wireremains in place. Releasable locking mechanism 66 comprises a toggleswitch 67 to alternate the mechanism between a lock and unlock position.

Referring to FIGS. 2A to 2C, another embodiment of the catheter systemcan comprise a distal tip 122 instead of distal tip 22. Distal tip 122in the embodiment shown is the same as distal tip 22 except that adistal portion of sidewall 152 defines a curved ramp 120 configured toguide distal end 34 a through side aperture 121. A portion of sidewall152 opposite and proximal to aperture 121 can also be sloped or ramping.The angle of the slope can align with entrance angle of ramp 120. Lumen123 is effectively a gap between the sloping surfaces, ramp 120 and thesloping sidewall 152. This gap is sized to accommodate needle wire 32.This gap can further be sized so that it does not accommodate catheter34. In some embodiments, distal tip 22 comprises a concave,straight-sided channel or groove in sidewall that gradually increases indepth in a distal to proximal direction, where the surface of channeldefines side aperture 21. This embodiment may be used with a catheter 34with or without a curved section 34 b.

In some embodiments, distal tip 122 comprises a channel that extendsfrom proximal end 122 a to an intermediate location between proximal end122 a and distal end 122 b. The channel gradually decreases in depth ina proximal-to-distal direction. The base of the channel is curved alongits length. Lumen 123 is in fluid communication with the channel.Proximal end 122 a of distal tip 122 is configured to couple (e.g.,mate) with distal end 18 b of shaft 18.

Distal tip can further comprise a second side aperture 43 opposite theside aperture 21 such that a line transverse to longitudinal axis passesthrough both apertures 21 and/or 43.

FIGS. 3A to 3I illustrate one embodiment of the present methods. Suchmethods can be performed using catheter systems described herein, but itis understood that the present methods can be performed using anysuitable catheter system. FIG. 3A shows a patient 10 with an occlusion13 involving a vessel 300 in neck region above the level of the superiorvena cava (SVC) and the right atrium near reference numeral 15. Asshown, a distal tip 22 of catheter 20 has approached occlusion 13. FIGS.3B-3H are schematic illustrations of a series of process steps, theillustration showing vessel 300 with a vessel occlusion 13 and thedistal portion of catheter system 12. FIG. 3I illustrates that theradiopaque target 30 placed on the surface of the patient 10 serves toset a desired exit site 40 on the skin of the patient and projectionangle θ.

A method for gaining access to a vessel (e.g., a vein, central venousvein, right internal jugular, superior vena cava, or other suitablevessel) can comprise applying a radiopaque target 30 defining aradiolucent area 31 to the skin of the patient so that the radiolucentarea defines a desired exit site 40 on the skin of the patient (FIG.3A). Catheter system 12 can then be introduced into the patient in anarea remote from exit site 40 (e.g., femoral vein) and advanced to adesired site in the vasculature (FIG. 3B). In the embodiment shown, thedesired site is in the vicinity of occlusion 13. In some embodiments, anintroducer catheter that has a lower stiffness than catheter 20 and/orcatheter system 12 is first inserted into the vessel (e.g., femoralvein) and serves as a guide for catheter system 12.

To facilitate locating the occlusion relative to catheter system 12, acontrast agent can be injected into the vasculature and a radiographicinstrument can be used to pin point the occlusion and the relativeposition of distal tip 22, which can comprise a radiopaque material. Theintroducer catheter can also have a radiopaque distal tip so that itslocation can be ascertained.

Once at the staging area, needle wire 32 can be advanced through thedistal end aperture 29 of the catheter beyond distal end 22 b and intoocclusion 13 (FIG. 3C). In some embodiments, radiographic imaging can beused to determine the depth of penetration into the occlusion. The depthof penetration can depend on the extent of occlusion 13. Pommel 25 canbe reciprocated as described above to advance needle wire 32. Sinceneedle wire 32 is not curved like catheter 34, it will advance past sideapertures (e.g., aperture 21, 401, and/or 42) and through distal endaperture 29. Needle wire 32 once inserted into the occlusion can definethe path of catheter 20 such that when catheter 20 is advanced distallyand pushed into the occlusion, it will follow the path of the needlewire.

Once in position, catheter 20 is advanced over needle wire 32 and intoocclusion 13 as well (FIG. 3D). Distal tip 22 can be pushed in to theocclusion by axial (along Y) and/or rotational forces (around Y) appliedto handle 28 attached to the proximal end of catheter 20. In someembodiments, radiographic imaging can be used to determine the depth ofpenetration into occlusion 13. The depth of penetration can depend onthe extent of occlusion 13.

To facilitate rotational alignment of the distal tip, distal tip 22 canbe viewed using a radiographic instrument (such as an x-ray detector,e.g., CT-scanner, fluoroscope, ultrasound detector, or the like) throughradiolucent area 31 of radiopaque target 30. Catheter 20 can be rotatedso that side aperture is aligned with or faces radiolucent area 31 (FIG.3E). The angle of the line extending between detector plane and distaltip 22 and to the longitudinal axis of patient or catheter (axis Y) canthen be ascertained. Such angle substantially corresponds to theprojection angle θ.

In some embodiments, the detector can be disposed on a C-arm. The angleof the C-arm relative to the patient can be used to determine theprojection angle θ. Once the desired tip location is achieved, forexample, the C-arm cranial angle is observed and it is used to determinethe projection angle θ. In general, the C-arm is moved to image the tip22 through the target 30. The angular location of distal tip 22 isdetermined by viewing side apertures 41 and/or 42 through target 30.FIG. 4 shows a schematic of the radiographic image. As tip 22 is rotatedaround its long axis the width and/or opacity of side apertures 41and/or 42 varies and this changing image feature is used to determinethe rotational orientation of distal tip 22.

FIG. 4 is a schematic view of a radiographic image that could beobserved by a user. Distal tip 22 has side apertures 41 and/or 42 thatcan be view through the central aperture 31 of radiopaque target 30. Theopacity of the apertures 41 and/or 42 can vary with the rotation ofcatheter 20. In general, apertures 41 and/or 42 will appear widestand/or brightest when one of aperture 41 and 42 is facing the centralaperture 31. A user can advance or retract the tip 22 and rotate thedistal tip 22 to optimize the exit path. Once the user has positionedthe distal tip at the desired position and rotated it to the desiredorientation, the projection angle θ can be ascertained from the C-arm.To set the projection angle θ, knob 16 is turned until the scale 17corresponds to the desired projection angle. The angular range can varybetween about 10 degrees to 90 degrees, e.g., 15 to 60 degrees asindicated on scale 17 or any other range between 10 to 90 degrees. Theadjustability of the tip combined with the use of fluoroscopic imagingallows a user to precisely position and aim the distal end of the needlewire. This ability to view and direct the needle wire enhances patientsafety.

Needle wire 32 can then be retracted from beyond aperture 29 intocatheter 20 and into catheter 34 (FIG. 3F). So as to not unduly effectthe axial movement of catheter 34, the distal end of the needle wire isretracted so that its distal end is disposed in a non-curved portion ofcatheter 34 (e.g., not disposed in curved section 34 b). In someembodiments, the distal end of needle wire 32 is spaced apart fromdistal end 34 a of the catheter 34 at least a distance that is notimpeding the curvature of catheter curved section 34 b, e.g., a distanceof 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, or more.

Catheter 34 can then be advanced a selected distance such that itextends from side aperture at the desired projection angle (FIG. 3G).Scale 17 can be used to ascertain the projection angle. Catheter 34positioned at the desired projection angle is aimed at radiolucent area31. Once catheter 34 is in position, needle wire 32 can be advancedthrough catheter 34 and into tissue, eventually through the skin of thepatient adjacent the radiolucent area of the radiopaque target (FIGS. 3Hand 3I). Distal end 32 a of needle wire 32 can then be exteriorized tothe patient.

With the needle wire 32 exteriorized as seen in the figure the accessprovided to the end of the wire allows additional intervention at theexit wound site as described below. For example, a dilation catheter canbe coupled to the exteriorized needle wire and the dilation catheter canbe drawn into the exit site by pulling on a proximal end of needle wire32 thereby forming a dilated tissue track. A guide wire can be insertedinto the dilation catheter and a medical device can be advanced over theguide wire along the dilated tissue track and into the vessel.

It should be understood that the foregoing device is broadly usable toestablish an access point to a patient's vasculature from the inside outat any desired location. Once the access point has been established, itcan be used for any desired medical procedure. For example, pacing leadsfor pacemakers can be delivered into a vessel after the tissue track hasbeen established, and treatment devices (such as steerable catheters)can be delivered to the vessel through the access point.

The above specification and examples provide a complete description ofthe structure and use of illustrative embodiments. Although certainembodiments have been described above with a certain degree ofparticularity, or with reference to one or more individual embodiments,those skilled in the art could make numerous alterations to thedisclosed embodiments without departing from the scope of thisinvention. As such, the various illustrative embodiments of the methodsand systems are not intended to be limited to the particular formsdisclosed. Rather, they include all modifications and alternativesfalling within the scope of the claims, and embodiments other than theone shown can include some or all of the features of the depictedembodiment. For example, elements can be omitted or combined as aunitary structure, and/or connections can be substituted. Further, whereappropriate, aspects of any of the examples described above can becombined with aspects of any of the other examples described to formfurther examples having comparable or different properties and/orfunctions, and addressing the same or different problems. Similarly, itwill be understood that the benefits and advantages described above canrelate to one embodiment or can relate to several embodiments.

The claims are not intended to include, and should not be interpreted toinclude, means-plus- or step-plus-function limitations, unless such alimitation is explicitly recited in a given claim using the phrase(s)“means for” or “step for,” respectively.

The invention claimed is:
 1. A catheter system comprising: a firstcatheter comprising: a shaft comprising a proximal end and a distal endextending along a longitudinal axis and defining a shaft lumen extendingtherebetween; a distal tip disposed at the distal end of the shaft anddefining a lumen extending along a longitudinal axis and in fluidcommunication with the shaft lumen and comprising a proximal end and adistal end, wherein the distal tip comprises a first side aperture influid communication with the shaft lumen and an exit aperture at thedistal end of the distal tip in fluid communication with the shaftlumen, the exit aperture defining an opening which is substantiallyparallel with the longitudinal axis of the shaft; wherein the firstcatheter is configured such that the distal tip can penetrate a vesselocclusion without deflection; a second catheter having a portionconfigured to extend through the shaft lumen and the first sideaperture, the second catheter comprising a proximal end and a distal endand defining a lumen along a longitudinal axis between the proximal endand the distal end, wherein the portion of the second catheter is curvedalong the longitudinal axis of the lumen and the curved portion iscloser to the distal end of the second catheter than the proximal end ofthe second catheter, wherein the first catheter and the second catheterare configured such that the distal end of the second catheter passesthrough the first side aperture of the first catheter when advancedthrough the first catheter; and a needle wire configured to extendthrough the second catheter lumen and to extend through the distal endexit aperture of the first catheter in a direction substantiallyparallel with the longitudinal axis of the shaft, the needle wire havinga sharp dissection tip, wherein the needle wire has a bending stiffnesssufficient to penetrate a muscle tissue without deflection from alocation within a vessel to a location exterior the body.
 2. Thecatheter system of claim 1, wherein the distal tip further comprises asecond side aperture and a radiopaque material defining at least aportion of the second side aperture.
 3. The catheter system of claim 2,wherein the distal tip further comprises a third side aperture locatedon the opposite side of the distal tip from the second side aperture,wherein the radiopaque material defines the third side aperture disposedopposite of the second side aperture.
 4. The catheter system of claim 1,for use in creating an access path from a location within a vessel to alocation on the skin of a patient.
 5. The catheter system of claim 4,wherein the vessel is the right internal jugular or the superior venacava.
 6. The catheter system of claim 1, wherein a distal portion of thefirst side aperture is defined by a surface that is a ramp configured toguide the second catheter through the first side aperture.
 7. Thecatheter system of claim 1, wherein a distal portion of the first sideaperture is defined by a curved surface.
 8. The catheter system of claim7, wherein the curved surface is a concave surface.
 9. The cathetersystem of claim 7, wherein the curved surface is an inclined surface,wherein an incline angle of the inclined surface is at an angle relativeto the longitudinal axis of the first catheter and sloped inward towardthe distal end of the shaft.
 10. The catheter system of claim 9, whereinthe distal tip comprises a sidewall body having an inner luminalsurface, wherein a portion of the inner luminal surface that is proximaland opposite to the first side aperture is a sloped surface.
 11. Thecatheter system of claim 1, wherein the distal tip further comprises asecond side aperture opposite the first side aperture such that a linetransverse to the longitudinal axis of the first catheter passes throughthe first and second side apertures.
 12. A catheter system comprising: afirst catheter comprising: a shaft comprising a proximal end and adistal end extending along a longitudinal axis and defining a shaftlumen extending therebetween; a distal tip disposed at the distal end ofthe shaft and defining a lumen extending along a longitudinal axis andin fluid communication with the shaft lumen and comprising a distal end,wherein the distal tip comprises a first, second, and third sideaperture in fluid communication with the shaft lumen and an exitaperture at the distal end of the distal tip in fluid communication withthe shaft lumen; wherein the second and/or third side aperture isconfigured to facilitate circumferential alignment of the firstcatheter; wherein the first catheter is configured such that the distaltip can penetrate a vessel occlusion without deflection; a secondcatheter having a portion configured to extend through the shaft lumenand the first side aperture, the second catheter comprising a proximalend and a distal end and defining a lumen along a longitudinal axisbetween the proximal end and the distal end, wherein the portion of thesecond catheter is curved along the longitudinal axis of the lumen andthe curved portion is closer to the distal end of the second catheterthan the proximal end of the second catheter, wherein the first catheterand the second catheter are configured such that the distal end of thesecond catheter passes through the first side aperture of the firstcatheter when advanced through the first catheter; and a needle wireconfigured to extend through the second catheter lumen and to extendthrough the distal end exit aperture of the first catheter in adirection substantially parallel with the longitudinal axis of theshaft, the needle wire having a sharp dissection tip, wherein the needlewire has a bending stiffness sufficient to penetrate a muscle tissuewithout deflection from a location within a vessel to a locationexterior the body.
 13. The catheter system of claim 12, wherein thedistal tip further comprises a second side aperture and a radiopaquematerial defining at least a portion of the second side aperture. 14.The catheter system of claim 13, wherein the distal tip furthercomprises the radiopaque material defining a third side aperturedisposed opposite of the second side aperture.
 15. The catheter systemof claim 12, wherein a distal portion of the first side aperture isdefined by a surface that is a ramp configured to guide the secondcatheter through the first side aperture.
 16. The catheter system ofclaim 12, wherein a distal portion of the first side aperture is definedby a curved surface.
 17. The catheter system of claim 16, wherein thecurved surface is a concave surface.
 18. The catheter system of claim16, wherein the curved surface is an inclined surface, wherein anincline angle of the inclined surface is at an angle relative to thelongitudinal axis of the first catheter and sloped inward toward thedistal end of the shaft.
 19. The catheter system of claim 18, whereinthe distal tip comprises a sidewall body having an inner luminalsurface, wherein a portion of the inner luminal surface that is proximaland opposite to the first side aperture is a sloped surface.
 20. Thecatheter system of claim 12, wherein the distal tip further comprises asecond side aperture opposite the first side aperture such that a linetransverse to the longitudinal axis of the first catheter passes throughthe first and second side apertures.